ACS group has an immediate need for a 'QC Instrument and Software Validation Specialist' with experience in the Pharmaceutical Industry. This is a 6 - month contract opportunity and is located in Devens, MA. Our client is a leading Pharmaceutical company.
Please review the job description below:
- Instrument validation
- software validation
Key Requirements and Technology Experience:
- Participate as part of a cross functional global project to qualify QC instruments and associated software.
- Support the implementations of a new standardized global qualification for QC instrumentation and associated software across five QC sites.
- Implement validation strategies for QC instrumentation and associated software, across QC Laboratories.
- Create, execute and review network led QC instrument/software qualification documents in support of global QC projects such as;
- Network QC Instrumentation Standardization and Windows 10 upgrades.
- Deployment of Enterprise Empower3 FR5 to QC sites including requalification of associated QC instruments.
- Author qualification related deviations, identifying root causes and robust CAPAs.
- Author qualification related change controls and validation plans.
- Update procedures and documents to implement data integrity controls arising from instrument qualification programmes.
- Serve as liaison with lab-IT teams to harmonise QC instrument's software configurations where applicable
- Ensure compliance with corporate policies, directives and current regulatory requirements for laboratory instrument qualification, lifecycle management, and computer system validation.
- Provide updates on qualification status, project timelines, and escalate challenges as required.
- Assist Network QC Equipment Lifecycle Lead in schedule development and workload management of project team
Qualifications and Experience required:
- Minimum of 2 years' experience in the pharmaceutical industry. It would be desirable to have at least 1 year experience in laboratory operational role.
- Demonstrated expertise in large projects within a complex high performance team,
- Desirable to have at least 1 year of experience in a role either (a) instrument qualification or (b) software validation, with detailed knowledge of regulatory requirements related to QC instruments and associated software
- Demonstrated ability to work independently as well as contribute to a team based collaborative environment and prioritise workload with minimum supervision as part of supporting multiple complex projects.
- Self-directed with a high degree of professional integrity, organization, and attention to detail.
- Strong interpersonal, oral and written communication skills are essential, including the ability to communicate at all levels with clarity and precision.
- Ability to work on multiple complex team projects where independent action and a high degree of initiative are required in resolving problems and developing recommendations.
- Ability to work across timelines and be available to travel when required.
- Demonstrated use of flexible thinking and growth mind-set is an advantage.
Candidate is expected to display the Behaviors, which enable them to be successful and perform at their highest level:
- Passion: We pursue excellence to help patients prevail.
- Innovation: We embrace new ideas.
- Accountability: We own our outcomes and the outcomes of others.
- Speed: We act with urgency and agility.
Thanks & Regards
P: (+1) 404-585-5612
ABOUT ACS GROUP. - ACS Group is a premier provider of IT Consulting, Engineering Consulting, Healthcare, Talent, and Workforce Management Solutions to Fortune 1000 companies globally. Our operating brands have provided targeted services and solutions for more than 50 years. We serve our clients through four operating companies:
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#Largest Minority-Owned IT Staffing Firm in the U.S. (2018 SIA)
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#Inavero's Best of Staffing® Client Diamond Award (2018).
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#Inavero's Best of Staffing®Client Diamond Award Winner(2017)